Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, rm. 1061Rockville, MD 20852All comments should be identified with the docket number FDA-2016-D-4414.

Questions?

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2373.

Contains Nonbinding Recommendations

November 2018

This guidance is intended for conventional food and dietary supplement manufacturers. It provides questions and answers on topics related to compliance with our final rules issued on May 27, 2016, entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742; the “Nutrition Facts label final rule”) and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000; the “serving size final rule”) (codified at title 21 of the Code of Federal Regulations, part 101 (21 CFR part 101)). This guidance also discusses labeling of added sugars, as well as formatting for lines (e.g. thickness of lines) and leading (e.g. space between lines) in the examples of graphics used by FDA on the Nutrition Facts label.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

In this guidance, “you” (or “I”) refers to a manufacturer of conventional food or dietary supplements.